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AZITHROMYCIN 200MG/5ML POWDER FOR ORAL SUSPENSION

Active substance(s): AZITHROMYCIN / AZITHROMYCIN MONOHYDRATE / AZITHROMYCIN / AZITHROMYCIN MONOHYDRATE / AZITHROMYCIN / AZITHROMYCIN MONOHYDRATE

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Rare (may affect up to 1 in 1000 people):
• Agitation
• A feeling of things being unreal
• Teeth discolouration
• Abnormal liver function, jaundice (yellowish
pigmentation of the skin)
• Reddening and blistering of the skin when
exposed to sunlight.
Not known (frequency cannot be estimated
from the available data):
• Blood disorders characterised by unusual
bleeding or unexplained bruising, low blood
count causing unusual tiredness or weakness
• Aggression, anxiety, confusion, seeing or
hearing things not really there
• Fainting, fits, loss of sensation, hyperactivity,
alteration or loss of the sense of smell, loss
of the sense of taste, myasthenia gravis (fatigue
and exhaustion of the muscle, see ‘Warnings
and precautions’ above)
• Hearing disturbances including deafness and/or
ringing in the ears
• Change in heart rate
• Low blood pressure (which may be associated
with weakness, light headedness and fainting)
• Discolouration of the tongue, inflammation of the
pancreas causing nausea, vomiting, abdominal
pain, back pain
• Liver failure (rarely life-threatening)
• Rash with spots and blisters
• Joint pain
• Kidney problems.
The following side effects have been reported
in prophylactic treatment against
Mycobacterium Avium Complex (MAC):
Very common (may affect more than 1 in 10
people)
• Diarrhea
• Abdominal pain
• Feeling sick (nausea)
• Loose wind (flatulence)
• Abdominal discomfort
• Loose stools.
Common (may affect up to1 in 10 people):
• Lack of appetite (anorexia)
• Feeling dizzy (dizziness)
• Headache
• Sensations of pins and needles or numbness
(paraesthesia)
• Changes in your sense of taste (dysgeusia)
• Visual impairment
• Deafness
• Skin rashes
• Itching (pruritus)
• Joint pain (arthralgia)
• Fatigue.
Uncommon (may affect up to 1 in 100 people):
• Reduced sense of touch (hypoesthesia)
• Hearing loss or ringing in your ears
• Abnormality of the rhythm or rate and awareness
of the heart beat (palpitations)
• Liver problems such as hepatitis
• Blisters/bleeding of the lips, eyes, nose, mouth
and genitals, which may be caused by
Stevens-Johnson syndrome
• Allergic skin reactions such as being sensitive to
sunlight, red, flaking and swollen skin
• Weakness (asthenia)
• General feeling of being unwell (malaise).
Reporting of side effects
If you get side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.

5. HOW TO STORE AZITHROMYCIN
• KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN
• Do not use Azithromycin after the expiry date
that is stated on the carton or bottle label. If
your doctor tells you to stop taking this
medicine, return any unused medicine to your
pharmacist or safe disposal. Only keep this
medicine, if your doctor tells you to.
• Unopened bottles: Do not store above 25°C.
• After reconstitution do not store above 25°C and
use within 10 days
• If your medicine becomes discoloured or shows
any other signs of deterioration, consult your
pharmacist who will tell you what to do.
• Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help to
protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Azithromycin contains
Each 5ml of reconstituted oral suspension
contains 200 mg azithromycin as
dihydrate.
The other ingredients are colloidal anhydrous
silica E551, sucrose, xanthan gum E415,
trisodium phosphate anhydrous,
hydroxypropyl cellulose, cherry flavouring trusil,
vanilla flavour, banana flavour.
What Azithromycin looks like and contents of
the pack
Azithromycin is a white to yellowish-white powder.
Azithromycin are available in bottles of 30ml.
A dosing syringe and dosing spoon are provided
with the bottles.
Manufacturer and Licence Holder
Manufactured by Teva Operations Poland Sp.
z.o.o., ul. Mogilska 80, 31-546 Krakow, Poland
and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1701 - Azithromycin
200mg/5ml Powder
for Oral Suspension

Leaflet revision date: 30/05/17

Blind or partially sighted?
Is this leaflet hard to see
or read? Phone
Lexon (UK) Limited,
Tel: 01527 505414 for
help.
Blue Box
Preparation of the suspension
Your pharmacist should prepare the
suspension. If you notice that this has not
been done, then you should go back to the
pharmacy to have the suspension prepared.

PATIENT INFORMATION LEAFLET

Ref: 1701/300517/1/F

Azithromycin 200mg/5ml Powder for Oral Suspension
Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor.
This includes any possible side effects not
listed in this leaflet. See section 4.
Your medicine is called Azithromycin 200mg/5ml
Powder for oral suspension and will be referred to
as Azithromycin throughout the rest of this leaflet.
What is in this leaflet:
1. What Azithromycin is and what it is used for
2. What you need to know before you use
Azithromycin
3. How to use Azithromycin
4. Possible side effects
5. How to store Azithromycin
6. Contents of the pack and other information
1. WHAT AZITHROMYCIN IS AND WHAT IT IS
USED FOR
Azithromycin is one of a group of antibiotics
called macrolides. It is used to treat bacterial
infections caused by microorganisms such as
bacteria. These infections include:
• Chest infections such as acute bronchitis and
pneumonia
• Infections in your sinuses, throat, tonsils or
ears
• Mild to moderate skin and soft tissue infections,
e.g. infection of the hair follicles (folliculitis),
bacterial infection of the skin and its deeper
layers (cellulitis), skin infection with shiny red
swelling (erysipelas)
• Infections caused by a bacterium called
Chlamydia trachomatis. They can cause
inflammations of the tube that carries urine from
your bladder (urethra) or where your womb joins
your vagina (cervix).
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE AZITHROMYCIN
Do NOT use Azithromycin:

• If you are allergic (hypersensitive) to
azithromycin or any other macrolide or ketolide
antibiotic, e.g. erythromycin or telithromycin or
any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
Talk to your doctor before taking azithromycin if
you:
• have ever had a serious allergic reaction
causing swelling of the face and throat, possibly
with breathing problems
• have severe kidney problems: your doctor
may alter the dose
• have liver problems: your doctor may need to
monitor your liver function or stop the treatment
• are aware of ever being diagnosed to have
prolonged QT interval (a heart condition):
azithromycin is not recommended
• are aware that you have a slow or irregular
heart beat, or reduced heart function:
azithromycin is not recommended
• know that you have low levels of potassium
or magnesium in your blood: azithromycin is not
recommended

• are taking medicines known as antiarrhythmics
(used to treat abnormal heart rhythms),
cisapride (used to treat stomach problems) or
terfenadine (an antihistamine that is used to
treat allergies):
azithromycin is not recommended
• are taking medicines known as ergot alkaloids
(such as ergotamine), which are used to treat
migraine: azithromycin is not recommended (see
‘Other medicines and Azithromycin’ below)
• have been diagnosed with a neurological
disease, which is a disease of the brain or
nervous system
• have mental, emotional or behavioural problems
• have a condition known as myasthenia gravis,
with fatigue and exhaustion of the muscles:
azithromycin may worsen or cause symptoms of
myasthenia.
If you develop severe and persistent diarrhoea
during or after treatment, especially if you notice
blood or mucus, tell your doctor immediately.
If your symptoms persist after the end of your
treatment with Azithromycin, or if you notice any
new and persistent symptoms, contact your
doctor.
Azithromycin is not recommended for patients
under 6 months of age.
Other medicines and azithromycin
Tell your doctor if you are taking, have recently
taken or might take any of the following
medicines:
• Antacids e.g. aluminium hydroxide: take
Azithromycin at least 1 hour before or 2
hours after taking an antacid
• Ergot derivatives, e.g. ergotamine (used to
treat migraine): Azithromycin should not be
taken at the same time as ergotism may develop
(a potentially serious side effect with numbness
or tingling sensations in the limbs, muscle
cramps, headaches, convulsions, abdominal or
chest pain)
• Coumarin type oral anticoagulants, e.g. warfarin
(used to stop the blood clotting): the risk of
bleeding may be increased
• Digoxin (used to treat heart failure): the levels of
digoxin in your blood may increase
• Zidovudine, nelfinavir (used in the treatment
of HIV): the levels of zidovudine or azithromycin
might be increased
• Rifabutin (used in the treatment of HIV and
bacterial infections including tuberculosis):
decreases in your number of white blood cells
could occur
• Cyclosporin (an immunosuppressant used
following organ transplant): cyclosporin levels
may be elevated. Your doctor will need to
monitor your cyclosporin blood levels
• Cisapride (used to treat stomach problems):
heart problems may occur
• Astemizole, terfenadine (antihistamines used
to treat allergic reactions): their effect might
be increased
• Alfentanil (a painkiller): the effect of alfentanil
might be increased
• Fluconazole (for fungal infections): the levels
of azithromycin might be reduced.

No interactions have been observed between
azithromycin and cetirizine (an antihistamine);
didanosine, efavirenz, indinavir (for HIV infection);
atorvastatin (for cholesterol and heart problems);
carbamazepine (for epilepsy); cimetidine (an
antacid); methylprednisolone (to suppress the
immune system); midazolam, triazolam
(sedatives); sildenafil (for impotence), theophylline
(for asthma) and trimethoprim/sulphamethoxazole
(an antibiotic combination).
AZITHROMYCIN with food and drink:
Oral suspension can be taken with or without
food and drink.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this
medicine.
There is insufficient information regarding the
safety of azithromycin during pregnancy and
breast-feeding. Consequently, Azithromycin is
not recommended if you are pregnant or planning
to become pregnant or breast-feeding.
However, your doctor may prescribe it under
serious circumstances.

Use in children and adolescents with a body
weight under 45 kg
The azithromycin suspension should be measured
as carefully as possible with the accompanying
dosing syringe for children with a weight of 10 to
15 kg. For children who weigh more than 15 kg,
the azithromycin suspension should be
administered with the help of the dosing spoon
according to the following plan:
Weight

3-day course

5-day course

10-15 kg

0.25 ml/kg
(10 mg/kg)
once daily on
days 1 to 3

0.25 ml/kg (10
mg/kg) once on
day 1, followed
by 0.125 ml
(5 mg/kg) once
daily on days 2
to 5

16-25 kg

5 ml (200 mg)
once daily on
days 1 to 3

5 ml (200 mg)
once on day 1,
followed by
2.5 ml
(100 mg) once
daily on days
2 to 5

26-35 kg

7.5 ml (300 mg)
once daily on
days 1 to 3

7.5 ml (300 mg)
once on day 1,
followed by
3.75 ml (150
mg) once daily
on days 2 to 5

Driving and using machines
Azithromycin is not expected to affect your ability
to drive or use machines.
Azithromycin powder for oral suspension contains
3.75 g of sucrose per 5 ml.
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.
The sucrose content should be taken into account
in patients with diabetes mellitus.
3. HOW TO USE AZITHROMYCIN
Always use Azithromycin exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.
Preparation of the suspension
By the pharmacist: your pharmacist should
prepare the suspension. If you notice that this was
not done, then you should go back to the
pharmacy to have the suspension prepared.
By yourself: follow the instructions in the blue box
of this leaflet. See blue box information.

35-45 kg

>45 kg

10 ml (400 mg)
once daily on
days 1 to 3

10 ml (400 mg)
once on day 1,
followed by
5 ml (200 mg)
once daily on
days 2 to 5

Dose as with
adults

For the treatment of tonsillitis/pharyngitis in
children aged 2 years or more: Azithromycin in
a single dose of 10 mg/kg or 20 mg/kg for three
days, in which the maximum daily dose of 500 mg
should not be exceeded.

Giving the medicine using the syringe
1. Make sure the child is supported in an upright
position.
2. Put the tip of the syringe carefully into the
child’s mouth. Point the tip of the syringe
towards the inside of the cheek.
3. Slowly push down the plunger of the syringe:
Do not squirt it out quickly. The medicine will
trickle into the child's mouth.
4. Allow the child time to swallow the medicine.
5. Replace the child-proof cap on the bottle.
Wash the syringe as instructed below.
6. Where daily doses of less than 5 ml have been
given for three days, some suspension will
remain in the bottle. This remaining suspension
should be discarded.

If you stop taking Azithromycin
Do not stop taking your medicine without talking
to your doctor first even if you feel better. It is very
important that you keep taking Azithromycin for as
long as your doctor has told you to, otherwise the
infection may come back.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Azithromycin can cause side
effects, although not everybody gets them.

Cleaning and storing the syringe
Pull the plunger out of the syringe and wash
both parts by holding under warm running water or
by immersing in sterilising solution used for baby’s
feeding bottles, etc.
Dry the two parts. Push the plunger back into the
syringe. Keep it in a clean safe place with the
medicine. After you have given the child the final
dose of medicine, wrap the syringe in a sheet of
newspaper and put it in the rubbish bin.

If the following happens, stop taking
Azithromycin and tell your doctor immediately
or go to the casualty department at your
nearest hospital:
• An allergic reaction (swelling of the lips, face
or neck leading to severe difficulty in breathing;
skin rash or hives)
• Blisters/bleeding of the lips, eyes, nose, mouth
and genitals, which may be caused by
Stevens-Johnson syndrome or toxic epidermal
necrosis, which are serious illnesses
• An irregular heart beat
• Prolonged diarrhoea with blood and mucus.

B. Instructions for the spoon
The spoon should not be used for children less
than 3 years of age (less than 15 kg).

These are very serious but rare side effects. You
may need urgent medical attention or
hospitalisation.

Giving the medicine using the plastic spoon
1. A plastic double-ended spoon is provided
with the medicine. Check which end of the
spoon and to which level gives the dose
required. If you are unsure, check with your
doctor or pharmacist. Multi-dosing spoon
delivers doses as follows:
2.5 ml (100mg)
Small end
brimful

The following other side effects have been
reported:
Very common (may affect more than 1 in 10
people):
• Diarrhoea.
Common (may affect up to 1 in 10 people):

• Changes in the numbers of some white blood
cells and blood bicarbonate

3.75 ml (150mg) Large end
5 ml (200mg)

Large end

to graduation

• Headache
• Vomiting, stomach pain, feeling sick.

brimful
Uncommon (may affect up to 1 in 100 people):

Sinusistis
For the treatment of sinusitis, limited data is
available for the treament of children under 16
years of age.
Patients with kidney or liver problems:
You should tell your doctor if you have kidney or
liver problems as your doctor may need to alter
the normal dose.

2. Shake the bottle well and then remove the
child-proof cap.
3. Gently pour the medicine into the spoon as
required to give the correct dose.
4. Allow the patient to swallow the medicine
slowly.
5. Wash the spoon under warm, running water.
Dry and store it with the medicine in a safe
place.

• Yeast infection e.g. of the mouth (thrush), vaginal

WARNING: GIVE THE MEDICINE SLOWLY TO
THE CHILD WHILE HE/SHE IS SUPPORTED IN
AN UPRIGHT POSITION. THIS WILL AVOID THE
RISK OF CHOKING.

• Sight disorders
• Ear disorders
• Vertigo (spinning sensation)
• Abnormality of the rhythm or rate and awareness

If you use more Azithromycin than you should
If you (or someone else) have taken too much
Azithromycin, contact your doctor or pharmacist
immediately. An overdose is likely to cause
reversible hearing loss, severe nausea (feeling
sick), vomiting and diarrhoea.

• Hot flush
• Difficulty breathing
• Nose bleed
• Inflammation of the stomach, constipation, wind,

infection, pneumonia, bacterial infection

• Sore throat, inflammation of the lining of the
stomach and the bowel, stuffy nose

• Blood disorders characterised by fever or chills,
sore throat, ulcers in your mouth or throat

• Allergic reactions
• Nervousness, difficulty sleeping
• Dizziness, sleepiness, taste disorders, pins and
needles or numbness

Dosage
Azithromycin suspension should be administered
in one single daily dose, with or without food.
Shake the bottle well before you use the
suspension.
The usual dose is:
Use in children and adolescents with a body
weight above 45 kg, adults and older people
The total dose of azithromycin is 37.5 ml
(1500 mg) over 3 days (12.5 ml (500 mg) once
daily). As an alternative, the dose can be
distributed over 5 days (12.5 ml (500 mg) as
one single dose on the first day and then 6.25 ml
(250 mg) once daily).
The dose for inflammation of the urethra or
cervix caused by Chlamydia is 25 ml (1000 mg)
in one single dose.
For sinusitis, treatment is aimed at adults and
adolescents over 16 years of age.

A. Instructions for the syringe
Filling the syringe with medicine
1. Shake the bottle before use and remove the
child-proof cap.
2. While the bottle is sitting on a firm, flat surface,
hold it steady with one hand. With the other
hand insert the tip of the syringe into the
suspension.
3. Slowly pull back the plunger of the syringe
so that the top edge of the black ring is level
with the graduation line indicated on the
syringe.
4. If large bubbles can be seen in the syringe,
slowly push the plunger back into the
syringe. This will force the medicine back
into the bottle. Repeat step 3 again.
5. Remove syringe from bottle.

of the heart beat (palpitations)

Please take this leaflet, any remaining medicine
and the container with you to the hospital or
doctor so that they know which medicine was
consumed.
If you forget to use Azithromycin
If you forget to take a dose, take that dose as
soon as you remember, unless it is nearly time
to take the next one. Do not take a double dose
to make up for a forgotten dose.

indigestion, difficulty swallowing

• Feeling bloated, dry mouth
• Belching, ulcers in the mouth, increased
salivation, loose stools

• Hepatitis (inflammation of the liver)
• Rash, itching, hives (nettle rash)
• Skin inflammation, dry skin, increased sweating
• Inflammation of the joint, muscle pain, back
pain, neck pain

• Painful and difficult urination
• Inflammation of the vagina, irregular menstrual
bleeding, testicle disorders

• Chest pain, swelling, feeling unwell, lethargy,
tiredness

• Swelling of the face, fever, pain
• Changes in liver enzymes and laboratory blood
values.

Ref: 1701/300517/1/B

Rare (may affect up to 1 in 1000 people):
• Agitation
• A feeling of things being unreal
• Teeth discolouration
• Abnormal liver function, jaundice (yellowish
pigmentation of the skin)
• Reddening and blistering of the skin when
exposed to sunlight.
Not known (frequency cannot be estimated
from the available data):
• Blood disorders characterised by unusual
bleeding or unexplained bruising, low blood
count causing unusual tiredness or weakness
• Aggression, anxiety, confusion, seeing or
hearing things not really there
• Fainting, fits, loss of sensation, hyperactivity,
alteration or loss of the sense of smell, loss
of the sense of taste, myasthenia gravis (fatigue
and exhaustion of the muscle, see ‘Warnings
and precautions’ above)
• Hearing disturbances including deafness and/or
ringing in the ears
• Change in heart rate
• Low blood pressure (which may be associated
with weakness, light headedness and fainting)
• Discolouration of the tongue, inflammation of the
pancreas causing nausea, vomiting, abdominal
pain, back pain
• Liver failure (rarely life-threatening)
• Rash with spots and blisters
• Joint pain
• Kidney problems.
The following side effects have been reported
in prophylactic treatment against
Mycobacterium Avium Complex (MAC):
Very common (may affect more than 1 in 10
people)
• Diarrhea
• Abdominal pain
• Feeling sick (nausea)
• Loose wind (flatulence)
• Abdominal discomfort
• Loose stools.
Common (may affect up to1 in 10 people):
• Lack of appetite (anorexia)
• Feeling dizzy (dizziness)
• Headache
• Sensations of pins and needles or numbness
(paraesthesia)
• Changes in your sense of taste (dysgeusia)
• Visual impairment
• Deafness
• Skin rashes
• Itching (pruritus)
• Joint pain (arthralgia)
• Fatigue.
Uncommon (may affect up to 1 in 100 people):
• Reduced sense of touch (hypoesthesia)
• Hearing loss or ringing in your ears
• Abnormality of the rhythm or rate and awareness
of the heart beat (palpitations)
• Liver problems such as hepatitis
• Blisters/bleeding of the lips, eyes, nose, mouth
and genitals, which may be caused by
Stevens-Johnson syndrome
• Allergic skin reactions such as being sensitive to
sunlight, red, flaking and swollen skin
• Weakness (asthenia)
• General feeling of being unwell (malaise).
Reporting of side effects
If you get side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.

PATIENT INFORMATION LEAFLET

5. HOW TO STORE AZITHROMYCIN

• KEEP OUT OF THE SIGHT AND REACH OF







CHILDREN
Do not use Azithromycin after the expiry date
that is stated on the carton or bottle label. If
your doctor tells you to stop taking this
medicine, return any unused medicine to your
pharmacist or safe disposal. Only keep this
medicine, if your doctor tells you to.
Unopened bottles: Do not store above 25°C.
After reconstitution do not store above 25°C and
use within 10 days.
If your medicine becomes discoloured or shows
any other signs of deterioration, consult your
pharmacist who will tell you what to do.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help to
protect the environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Azithromycin contains
Each 5ml of reconstituted oral suspension
contains 200 mg azithromycin as dihydrate.
The other ingredients are colloidal anhydrous
silica E551, sucrose, xanthan gum E415,
trisodium phosphate anhydrous,
hydroxypropyl cellulose, cherry flavouring trusil,
vanilla flavour, banana flavour.
What Azithromycin looks like and contents of
the pack
Azithromycin is a white to yellowish-white powder.
Azithromycin are available in bottles of 30ml.
A dosing syringe and dosing spoon are provided
with the bottles.
Manufacturer and Licence Holder
Manufactured by TEVA UK Ltd, Brampton Road,
Hampden Park, Eastbourne, East Sussex,
BN22 9AG, UK and is procured from within the EU
and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1701 - Azithromycin
200mg/5ml Powder
for Oral Suspension

Leaflet revision date: 30/05/17

Blind or partially sighted?
Is this leaflet hard to see
or read? Phone
Lexon (UK) Limited,
Tel: 01527 505414 for
help.
Blue Box
Preparation of the suspension
Your pharmacist should prepare the
suspension. If you notice that this has not
been done, then you should go back to the
pharmacy to have the suspension prepared.

Ref: 1701/300517/2/F

Azithromycin 200mg/5ml Powder for Oral Suspension
Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor.
This includes any possible side effects not
listed in this leaflet. See section 4.
Your medicine is called Azithromycin 200mg/5ml
Powder for oral suspension and will be referred to
as Azithromycin throughout the rest of this leaflet.
What is in this leaflet:
1. What Azithromycin is and what it is used for
2. What you need to know before you use
Azithromycin
3. How to use Azithromycin
4. Possible side effects
5. How to store Azithromycin
6. Contents of the pack and other information
1. WHAT AZITHROMYCIN IS AND WHAT IT IS
USED FOR
Azithromycin is one of a group of antibiotics
called macrolides. It is used to treat bacterial
infections caused by microorganisms such as
bacteria. These infections include:
• Chest infections such as acute bronchitis and
pneumonia
• Infections in your sinuses, throat, tonsils or
ears
• Mild to moderate skin and soft tissue infections,
e.g. infection of the hair follicles (folliculitis),
bacterial infection of the skin and its deeper
layers (cellulitis), skin infection with shiny red
swelling (erysipelas)
• Infections caused by a bacterium called
Chlamydia trachomatis. They can cause
inflammations of the tube that carries urine from
your bladder (urethra) or where your womb joins
your vagina (cervix).
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE AZITHROMYCIN
Do NOT use Azithromycin:

• If you are allergic (hypersensitive) to
azithromycin or any other macrolide or ketolide
antibiotic, e.g. erythromycin or telithromycin or
any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
Talk to your doctor before taking azithromycin if
you:
• have ever had a serious allergic reaction
causing swelling of the face and throat, possibly
with breathing problems
• have severe kidney problems: your doctor
may alter the dose
• have liver problems: your doctor may need to
monitor your liver function or stop the treatment
• are aware of ever being diagnosed to have
prolonged QT interval (a heart condition):
azithromycin is not recommended
• are aware that you have a slow or irregular
heart beat, or reduced heart function:
azithromycin is not recommended
• know that you have low levels of potassium
or magnesium in your blood: azithromycin is not
recommended

• are taking medicines known as antiarrhythmics
(used to treat abnormal heart rhythms), cisapride
(used to treat stomach problems) or terfenadine
(an antihistamine that is used to treat allergies):
azithromycin is not recommended
• are taking medicines known as ergot alkaloids
(such as ergotamine), which are used to treat
migraine: azithromycin is not recommended (see
‘Other medicines and Azithromycin’ below)
• have been diagnosed with a neurological
disease, which is a disease of the brain or
nervous system
• have mental, emotional or behavioural problems
• have a condition known as myasthenia gravis,
with fatigue and exhaustion of the muscles:
azithromycin may worsen or cause symptoms of
myasthenia.
If you develop severe and persistent diarrhoea
during or after treatment, especially if you notice
blood or mucus, tell your doctor immediately.
If your symptoms persist after the end of your
treatment with Azithromycin, or if you notice any
new and persistent symptoms, contact your
doctor.
Azithromycin is not recommended for patients
under 6 months of age.
Other medicines and azithromycin
Tell your doctor if you are taking, have recently
taken or might take any of the following
medicines:
• Antacids e.g. aluminium hydroxide: take
Azithromycin at least 1 hour before or 2
hours after taking an antacid
• Ergot derivatives, e.g. ergotamine (used to
treat migraine): Azithromycin should not be
taken at the same time as ergotism may develop
(a potentially serious side effect with numbness
or tingling sensations in the limbs, muscle
cramps, headaches, convulsions, abdominal or
chest pain)
• Coumarin type oral anticoagulants, e.g. warfarin
(used to stop the blood clotting): the risk of
bleeding may be increased
• Digoxin (used to treat heart failure): the levels of
digoxin in your blood may increase
• Zidovudine, nelfinavir (used in the treatment
of HIV): the levels of zidovudine or azithromycin
might be increased
• Rifabutin (used in the treatment of HIV and
bacterial infections including tuberculosis):
decreases in your number of white blood cells
could occur
• Cyclosporin (an immunosuppressant used
following organ transplant): cyclosporin levels
may be elevated. Your doctor will need to
monitor your cyclosporin blood levels
• Cisapride (used to treat stomach problems):
heart problems may occur
• Astemizole, terfenadine (antihistamines used
to treat allergic reactions): their effect might
be increased
• Alfentanil (a painkiller): the effect of alfentanil
might be increased
• Fluconazole (for fungal infections): the levels
of azithromycin might be reduced.

No interactions have been observed between
azithromycin and cetirizine (an antihistamine);
didanosine, efavirenz, indinavir (for HIV infection);
atorvastatin (for cholesterol and heart problems);
carbamazepine (for epilepsy); cimetidine (an
antacid); methylprednisolone (to suppress the
immune system); midazolam, triazolam
(sedatives); sildenafil (for impotence), theophylline
(for asthma) and trimethoprim/sulphamethoxazole
(an antibiotic combination).
AZITHROMYCIN with food and drink:
Oral suspension can be taken with or without
food and drink.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this
medicine.
There is insufficient information regarding the
safety of azithromycin during pregnancy and
breast-feeding. Consequently, Azithromycin is
not recommended if you are pregnant or planning
to become pregnant or breast-feeding.
However, your doctor may prescribe it under
serious circumstances.

Use in children and adolescents with a body
weight under 45 kg
The azithromycin suspension should be measured
as carefully as possible with the accompanying
dosing syringe for children with a weight of 10 to
15 kg. For children who weigh more than 15 kg,
the azithromycin suspension should be
administered with the help of the dosing spoon
according to the following plan:
Weight

3-day course

5-day course

10-15 kg

0.25 ml/kg
(10 mg/kg)
once daily on
days 1 to 3

0.25 ml/kg (10
mg/kg) once on
day 1, followed
by 0.125 ml
(5 mg/kg) once
daily on days 2
to 5

16-25 kg

5 ml (200 mg)
once daily on
days 1 to 3

5 ml (200 mg)
once on day 1,
followed by
2.5 ml
(100 mg) once
daily on days
2 to 5

26-35 kg

7.5 ml (300 mg)
once daily on
days 1 to 3

7.5 ml (300 mg)
once on day 1,
followed by
3.75 ml (150
mg) once daily
on days 2 to 5

Driving and using machines
Azithromycin is not expected to affect your ability
to drive or use machines.
Azithromycin powder for oral suspension contains
3.75 g of sucrose per 5 ml.

35-45 kg

10 ml (400 mg)
once daily on
days 1 to 3

If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.
>45 kg

The sucrose content should be taken into account
in patients with diabetes mellitus.
3. HOW TO USE AZITHROMYCIN
Always use Azithromycin exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.
Preparation of the suspension
By the pharmacist: your pharmacist should
prepare the suspension. If you notice that this was
not done, then you should go back to the
pharmacy to have the suspension prepared.
By yourself: follow the instructions in the blue box
of this leaflet. See blue box information.
Dosage
Azithromycin suspension should be administered
in one single daily dose, with or without food.
Shake the bottle well before you use the
suspension.
The usual dose is:
Use in children and adolescents with a body
weight above 45 kg, adults and older people
The total dose of azithromycin is 37.5 ml
(1500 mg) over 3 days (12.5 ml (500 mg) once
daily). As an alternative, the dose can be
distributed over 5 days (12.5 ml (500 mg) as
one single dose on the first day and then 6.25 ml
(250 mg) once daily).
The dose for inflammation of the urethra or
cervix caused by Chlamydia is 25 ml (1000 mg)
in one single dose.
For sinusitis, treatment is aimed at adults and
adolescents over 16 years of age.

10 ml (400 mg)
once on day 1,
followed by
5 ml (200 mg)
once daily on
days 2 to 5

Dose as with
adults

For the treatment of tonsillitis/pharyngitis in
children aged 2 years or more: Azithromycin in
a single dose of 10 mg/kg or 20 mg/kg for three
days, in which the maximum daily dose of 500 mg
should not be exceeded.

Giving the medicine using the syringe
1. Make sure the child is supported in an upright
position.
2. Put the tip of the syringe carefully into the
child’s mouth. Point the tip of the syringe
towards the inside of the cheek.
3. Slowly push down the plunger of the syringe:
Do not squirt it out quickly. The medicine will
trickle into the child's mouth.
4. Allow the child time to swallow the medicine.
5. Replace the child-proof cap on the bottle.
Wash the syringe as instructed below.
6. Where daily doses of less than 5 ml have been
given for three days, some suspension will
remain in the bottle. This remaining suspension
should be discarded.

If you stop taking Azithromycin
Do not stop taking your medicine without talking
to your doctor first even if you feel better. It is very
important that you keep taking Azithromycin for as
long as your doctor has told you to, otherwise the
infection may come back.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Azithromycin can cause side
effects, although not everybody gets them.

Cleaning and storing the syringe
Pull the plunger out of the syringe and wash
both parts by holding under warm running water or
by immersing in sterilising solution used for baby’s
feeding bottles, etc.
Dry the two parts. Push the plunger back into the
syringe. Keep it in a clean safe place with the
medicine. After you have given the child the final
dose of medicine, wrap the syringe in a sheet of
newspaper and put it in the rubbish bin.

If the following happens, stop taking
Azithromycin and tell your doctor immediately
or go to the casualty department at your
nearest hospital:
• An allergic reaction (swelling of the lips, face
or neck leading to severe difficulty in breathing;
skin rash or hives)
• Blisters/bleeding of the lips, eyes, nose, mouth
and genitals, which may be caused by
Stevens-Johnson syndrome or toxic epidermal
necrosis, which are serious illnesses
• An irregular heart beat
• Prolonged diarrhoea with blood and mucus.

B. Instructions for the spoon
The spoon should not be used for children less
than 3 years of age (less than 15 kg).

These are very serious but rare side effects. You
may need urgent medical attention or
hospitalisation.

Giving the medicine using the plastic spoon
1. A plastic double-ended spoon is provided
with the medicine. Check which end of the
spoon and to which level gives the dose
required. If you are unsure, check with your
doctor or pharmacist. Multi-dosing spoon
delivers doses as follows:
2.5 ml (100mg)
Small end
brimful

The following other side effects have been
reported:
Very common (may affect more than 1 in 10
people):
• Diarrhoea.
Common (may affect up to 1 in 10 people):

• Changes in the numbers of some white blood
cells and blood bicarbonate

3.75 ml (150mg) Large end
5 ml (200mg)

Large end

to graduation

• Headache
• Vomiting, stomach pain, feeling sick.

brimful
Uncommon (may affect up to 1 in 100 people):

Sinusistis
For the treatment of sinusitis, limited data is
available for the treament of children under 16
years of age.
Patients with kidney or liver problems:
You should tell your doctor if you have kidney or
liver problems as your doctor may need to alter
the normal dose.

2. Shake the bottle well and then remove the
child-proof cap.
3. Gently pour the medicine into the spoon as
required to give the correct dose.
4. Allow the patient to swallow the medicine
slowly.
5. Wash the spoon under warm, running water.
Dry and store it with the medicine in a safe
place.

• Yeast infection e.g. of the mouth (thrush), vaginal

WARNING: GIVE THE MEDICINE SLOWLY TO
THE CHILD WHILE HE/SHE IS SUPPORTED IN
AN UPRIGHT POSITION. THIS WILL AVOID THE
RISK OF CHOKING.

• Sight disorders
• Ear disorders
• Vertigo (spinning sensation)
• Abnormality of the rhythm or rate and awareness

If you use more Azithromycin than you should
If you (or someone else) have taken too much
Azithromycin, contact your doctor or pharmacist
immediately. An overdose is likely to cause
reversible hearing loss, severe nausea (feeling
sick), vomiting and diarrhoea.

• Hot flush
• Difficulty breathing
• Nose bleed
• Inflammation of the stomach, constipation, wind,

infection, pneumonia, bacterial infection

• Sore throat, inflammation of the lining of the
stomach and the bowel, stuffy nose

• Blood disorders characterised by fever or chills,
sore throat, ulcers in your mouth or throat

• Allergic reactions
• Nervousness, difficulty sleeping
• Dizziness, sleepiness, taste disorders, pins and
needles or numbness

A. Instructions for the syringe
Filling the syringe with medicine
1. Shake the bottle before use and remove the
child-proof cap.
2. While the bottle is sitting on a firm, flat surface,
hold it steady with one hand. With the other
hand insert the tip of the syringe into the
suspension.
3. Slowly pull back the plunger of the syringe
so that the top edge of the black ring is level
with the graduation line indicated on the
syringe.
4. If large bubbles can be seen in the syringe,
slowly push the plunger back into the
syringe. This will force the medicine back
into the bottle. Repeat step 3 again.
5. Remove syringe from bottle.

of the heart beat (palpitations)

Please take this leaflet, any remaining medicine
and the container with you to the hospital or
doctor so that they know which medicine was
consumed.
If you forget to use Azithromycin
If you forget to take a dose, take that dose as
soon as you remember, unless it is nearly time
to take the next one. Do not take a double dose
to make up for a forgotten dose.

indigestion, difficulty swallowing

• Feeling bloated, dry mouth
• Belching, ulcers in the mouth, increased
salivation, loose stools

• Hepatitis (inflammation of the liver)
• Rash, itching, hives (nettle rash)
• Skin inflammation, dry skin, increased sweating
• Inflammation of the joint, muscle pain, back
pain, neck pain

• Painful and difficult urination
• Inflammation of the vagina, irregular menstrual
bleeding, testicle disorders

• Chest pain, swelling, feeling unwell, lethargy,
tiredness

• Swelling of the face, fever, pain
• Changes in liver enzymes and laboratory blood
values.

Ref: 1701/300517/2/B

Rare (may affect up to 1 in 1000 people):
• Agitation
• A feeling of things being unreal
• Teeth discolouration
• Abnormal liver function, jaundice (yellowish
pigmentation of the skin)
• Reddening and blistering of the skin when
exposed to sunlight.
Not known (frequency cannot be estimated
from the available data):
• Blood disorders characterised by unusual
bleeding or unexplained bruising, low blood
count causing unusual tiredness or weakness
• Aggression, anxiety, confusion, seeing or
hearing things not really there
• Fainting, fits, loss of sensation, hyperactivity,
alteration or loss of the sense of smell, loss
of the sense of taste, myasthenia gravis (fatigue
and exhaustion of the muscle, see ‘Warnings
and precautions’ above)
• Hearing disturbances including deafness and/or
ringing in the ears
• Change in heart rate
• Low blood pressure (which may be associated
with weakness, light headedness and fainting)
• Discolouration of the tongue, inflammation of the
pancreas causing nausea, vomiting, abdominal
pain, back pain
• Liver failure (rarely life-threatening)
• Rash with spots and blisters
• Joint pain
• Kidney problems.
The following side effects have been reported
in prophylactic treatment against
Mycobacterium Avium Complex (MAC):
Very common (may affect more than 1 in 10
people)
• Diarrhea
• Abdominal pain
• Feeling sick (nausea)
• Loose wind (flatulence)
• Abdominal discomfort
• Loose stools.
Common (may affect up to1 in 10 people):
• Lack of appetite (anorexia)
• Feeling dizzy (dizziness)
• Headache
• Sensations of pins and needles or numbness
(paraesthesia)
• Changes in your sense of taste (dysgeusia)
• Visual impairment
• Deafness
• Skin rashes
• Itching (pruritus)
• Joint pain (arthralgia)
• Fatigue.
Uncommon (may affect up to 1 in 100 people):
• Reduced sense of touch (hypoesthesia)
• Hearing loss or ringing in your ears
• Abnormality of the rhythm or rate and awareness
of the heart beat (palpitations)
• Liver problems such as hepatitis
• Blisters/bleeding of the lips, eyes, nose, mouth
and genitals, which may be caused by
Stevens-Johnson syndrome
• Allergic skin reactions such as being sensitive to
sunlight, red, flaking and swollen skin
• Weakness (asthenia)
• General feeling of being unwell (malaise).
Reporting of side effects
If you get side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.

PATIENT INFORMATION LEAFLET

5. HOW TO STORE AZITHROMYCIN









KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN
Do not use Azithromycin after the expiry date
that is stated on the carton or bottle label. If
your doctor tells you to stop taking this
medicine, return any unused medicine to your
pharmacist or safe disposal. Only keep this
medicine, if your doctor tells you to.
Unopened bottles: Do not store above 25°C.
After reconstitution do not store above 25°C
and use within 10 days.
If your medicine becomes discoloured or shows
any other signs of deterioration, consult your
pharmacist who will tell you what to do.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help to
protect the environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Azithromycin contains
Each 5ml of reconstituted oral suspension
contains 200 mg azithromycin as dihydrate.
The other ingredients are colloidal anhydrous
silica E551, sucrose, xanthan gum E415,
trisodium phosphate anhydrous,
hydroxypropyl cellulose, cherry flavouring trusil,
vanilla flavour, banana flavour.
What Azithromycin looks like and contents of
the pack
Azithromycin is a white to yellowish-white powder.
Azithromycin are available in bottles of 30ml.
A dosing syringe and dosing spoon are provided
with the bottles.
Manufacturer and Licence Holder
Manufactured by PLIVA Croatia Ltd, Prilaz baruna
Filipovica 25, 10000 Zagreb, Croatia and is
procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1701 - Azithromycin
200mg/5ml Powder
for Oral Suspension

Leaflet revision date: 30/05/17

Blind or partially sighted?
Is this leaflet hard to see
or read? Phone
Lexon (UK) Limited,
Tel: 01527 505414 for
help.
Blue Box
Preparation of the suspension
Your pharmacist should prepare the
suspension. If you notice that this has not
been done, then you should go back to the
pharmacy to have the suspension prepared.

Ref: 1701/300517/3/F

Azithromycin 200mg/5ml Powder for Oral Suspension
Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor.
This includes any possible side effects not
listed in this leaflet. See section 4.
Your medicine is called Azithromycin 200mg/5ml
Powder for oral suspension and will be referred to
as Azithromycin throughout the rest of this leaflet.
What is in this leaflet:
1. What Azithromycin is and what it is used for
2. What you need to know before you use
Azithromycin
3. How to use Azithromycin
4. Possible side effects
5. How to store Azithromycin
6. Contents of the pack and other information
1. WHAT AZITHROMYCIN IS AND WHAT IT IS
USED FOR
Azithromycin is one of a group of antibiotics
called macrolides. It is used to treat bacterial
infections caused by microorganisms such as
bacteria. These infections include:
• Chest infections such as acute bronchitis and
pneumonia
• Infections in your sinuses, throat, tonsils or
ears
• Mild to moderate skin and soft tissue infections,
e.g. infection of the hair follicles (folliculitis),
bacterial infection of the skin and its deeper
layers (cellulitis), skin infection with shiny red
swelling (erysipelas)
• Infections caused by a bacterium called
Chlamydia trachomatis. They can cause
inflammations of the tube that carries urine from
your bladder (urethra) or where your womb joins
your vagina (cervix).
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE AZITHROMYCIN
Do NOT use Azithromycin:

• If you are allergic (hypersensitive) to
azithromycin or any other macrolide or ketolide
antibiotic, e.g. erythromycin or telithromycin or
any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
Talk to your doctor before taking azithromycin if
you:
• have ever had a serious allergic reaction
causing swelling of the face and throat, possibly
with breathing problems
• have severe kidney problems: your doctor
may alter the dose
• have liver problems: your doctor may need to
monitor your liver function or stop the treatment
• are aware of ever being diagnosed to have
prolonged QT interval (a heart condition):
azithromycin is not recommended
• are aware that you have a slow or irregular
heart beat, or reduced heart function:
azithromycin is not recommended
• know that you have low levels of potassium
or magnesium in your blood: azithromycin is not
recommended

• are taking medicines known as antiarrhythmics
(used to treat abnormal heart rhythms), cisapride
(used to treat stomach problems) or terfenadine
(an antihistamine that is used to treat allergies):
azithromycin is not recommended
• are taking medicines known as ergot alkaloids
(such as ergotamine), which are used to treat
migraine: azithromycin is not recommended (see
‘Other medicines and Azithromycin’ below)
• have been diagnosed with a neurological
disease, which is a disease of the brain or
nervous system
• have mental, emotional or behavioural problems
• have a condition known as myasthenia gravis,
with fatigue and exhaustion of the muscles:
azithromycin may worsen or cause symptoms of
myasthenia.
If you develop severe and persistent diarrhoea
during or after treatment, especially if you notice
blood or mucus, tell your doctor immediately.
If your symptoms persist after the end of your
treatment with Azithromycin, or if you notice any
new and persistent symptoms, contact your
doctor.
Azithromycin is not recommended for patients
under 6 months of age.
Other medicines and azithromycin
Tell your doctor if you are taking, have recently
taken or might take any of the following
medicines:
• Antacids e.g. aluminium hydroxide: take
Azithromycin at least 1 hour before or 2
hours after taking an antacid
• Ergot derivatives, e.g. ergotamine (used to
treat migraine): Azithromycin should not be
taken at the same time as ergotism may develop
(a potentially serious side effect with numbness
or tingling sensations in the limbs, muscle
cramps, headaches, convulsions, abdominal or
chest pain)
• Coumarin type oral anticoagulants, e.g. warfarin
(used to stop the blood clotting): the risk of
bleeding may be increased
• Digoxin (used to treat heart failure): the levels of
digoxin in your blood may increase
• Zidovudine, nelfinavir (used in the treatment
of HIV): the levels of zidovudine or azithromycin
might be increased
• Rifabutin (used in the treatment of HIV and
bacterial infections including tuberculosis):
decreases in your number of white blood cells
could occur
• Cyclosporin (an immunosuppressant used
following organ transplant): cyclosporin levels
may be elevated. Your doctor will need to
monitor your cyclosporin blood levels
• Cisapride (used to treat stomach problems):
heart problems may occur
• Astemizole, terfenadine (antihistamines used
to treat allergic reactions): their effect might
be increased
• Alfentanil (a painkiller): the effect of alfentanil
might be increased
• Fluconazole (for fungal infections): the levels
of azithromycin might be reduced.

No interactions have been observed between
azithromycin and cetirizine (an antihistamine);
didanosine, efavirenz, indinavir (for HIV infection);
atorvastatin (for cholesterol and heart problems);
carbamazepine (for epilepsy); cimetidine (an
antacid); methylprednisolone (to suppress the
immune system); midazolam, triazolam
(sedatives); sildenafil (for impotence), theophylline
(for asthma) and trimethoprim/sulphamethoxazole
(an antibiotic combination).
AZITHROMYCIN with food and drink:
Oral suspension can be taken with or without
food and drink.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this
medicine.
There is insufficient information regarding the
safety of azithromycin during pregnancy and
breast-feeding. Consequently, Azithromycin is
not recommended if you are pregnant or planning
to become pregnant or breast-feeding.
However, your doctor may prescribe it under
serious circumstances.

Use in children and adolescents with a body
weight under 45 kg
The azithromycin suspension should be measured
as carefully as possible with the accompanying
dosing syringe for children with a weight of 10 to
15 kg. For children who weigh more than 15 kg,
the azithromycin suspension should be
administered with the help of the dosing spoon
according to the following plan:
Weight

3-day course

5-day course

10-15 kg

0.25 ml/kg
(10 mg/kg)
once daily on
days 1 to 3

0.25 ml/kg (10
mg/kg) once on
day 1, followed
by 0.125 ml
(5 mg/kg) once
daily on days 2
to 5

16-25 kg

5 ml (200 mg)
once daily on
days 1 to 3

5 ml (200 mg)
once on day 1,
followed by
2.5 ml
(100 mg) once
daily on days
2 to 5

26-35 kg

7.5 ml (300 mg)
once daily on
days 1 to 3

7.5 ml (300 mg)
once on day 1,
followed by
3.75 ml (150
mg) once daily
on days 2 to 5

Driving and using machines
Azithromycin is not expected to affect your ability
to drive or use machines.
Azithromycin powder for oral suspension contains
3.75 g of sucrose per 5 ml.
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.
The sucrose content should be taken into account
in patients with diabetes mellitus.
3. HOW TO USE AZITHROMYCIN
Always use Azithromycin exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.
Preparation of the suspension
By the pharmacist: your pharmacist should
prepare the suspension. If you notice that this was
not done, then you should go back to the
pharmacy to have the suspension prepared.
By yourself: follow the instructions in the blue box
of this leaflet. See blue box information.

35-45 kg

>45 kg

10 ml (400 mg)
once daily on
days 1 to 3

10 ml (400 mg)
once on day 1,
followed by
5 ml (200 mg)
once daily on
days 2 to 5

Dose as with
adults

For the treatment of tonsillitis/pharyngitis in
children aged 2 years or more: Azithromycin in
a single dose of 10 mg/kg or 20 mg/kg for three
days, in which the maximum daily dose of 500 mg
should not be exceeded.

Giving the medicine using the syringe
1. Make sure the child is supported in an upright
position.
2. Put the tip of the syringe carefully into the
child’s mouth. Point the tip of the syringe
towards the inside of the cheek.
3. Slowly push down the plunger of the syringe:
Do not squirt it out quickly. The medicine will
trickle into the child's mouth.
4. Allow the child time to swallow the medicine.
5. Replace the child-proof cap on the bottle.
Wash the syringe as instructed below.
6. Where daily doses of less than 5 ml have been
given for three days, some suspension will
remain in the bottle. This remaining suspension
should be discarded.

If you stop taking Azithromycin
Do not stop taking your medicine without talking
to your doctor first even if you feel better. It is very
important that you keep taking Azithromycin for as
long as your doctor has told you to, otherwise the
infection may come back.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Azithromycin can cause side
effects, although not everybody gets them.

Cleaning and storing the syringe
Pull the plunger out of the syringe and wash
both parts by holding under warm running water or
by immersing in sterilising solution used for baby’s
feeding bottles, etc.
Dry the two parts. Push the plunger back into the
syringe. Keep it in a clean safe place with the
medicine. After you have given the child the final
dose of medicine, wrap the syringe in a sheet of
newspaper and put it in the rubbish bin.

If the following happens, stop taking
Azithromycin and tell your doctor immediately
or go to the casualty department at your
nearest hospital:
• An allergic reaction (swelling of the lips, face
or neck leading to severe difficulty in breathing;
skin rash or hives)
• Blisters/bleeding of the lips, eyes, nose, mouth
and genitals, which may be caused by
Stevens-Johnson syndrome or toxic epidermal
necrosis, which are serious illnesses
• An irregular heart beat
• Prolonged diarrhoea with blood and mucus.

B. Instructions for the spoon
The spoon should not be used for children less
than 3 years of age (less than 15 kg).

These are very serious but rare side effects. You
may need urgent medical attention or
hospitalisation.

Giving the medicine using the plastic spoon
1. A plastic double-ended spoon is provided
with the medicine. Check which end of the
spoon and to which level gives the dose
required. If you are unsure, check with your
doctor or pharmacist. Multi-dosing spoon
delivers doses as follows:
2.5 ml (100mg)
Small end
brimful

The following other side effects have been
reported:
Very common (may affect more than 1 in 10
people):
• Diarrhoea.
Common (may affect up to 1 in 10 people):

• Changes in the numbers of some white blood
cells and blood bicarbonate

3.75 ml (150mg) Large end
5 ml (200mg)

Large end

to graduation

• Headache
• Vomiting, stomach pain, feeling sick.

brimful
Uncommon (may affect up to 1 in 100 people):

Sinusistis
For the treatment of sinusitis, limited data is
available for the treament of children under 16
years of age.
Patients with kidney or liver problems:
You should tell your doctor if you have kidney or
liver problems as your doctor may need to alter
the normal dose.

2. Shake the bottle well and then remove the
child-proof cap.
3. Gently pour the medicine into the spoon as
required to give the correct dose.
4. Allow the patient to swallow the medicine
slowly.
5. Wash the spoon under warm, running water.
Dry and store it with the medicine in a safe
place.

• Yeast infection e.g. of the mouth (thrush), vaginal

WARNING: GIVE THE MEDICINE SLOWLY TO
THE CHILD WHILE HE/SHE IS SUPPORTED IN
AN UPRIGHT POSITION. THIS WILL AVOID THE
RISK OF CHOKING.

• Sight disorders
• Ear disorders
• Vertigo (spinning sensation)
• Abnormality of the rhythm or rate and awareness

If you use more Azithromycin than you should
If you (or someone else) have taken too much
Azithromycin, contact your doctor or pharmacist
immediately. An overdose is likely to cause
reversible hearing loss, severe nausea (feeling
sick), vomiting and diarrhoea.

• Hot flush
• Difficulty breathing
• Nose bleed
• Inflammation of the stomach, constipation, wind,

infection, pneumonia, bacterial infection

• Sore throat, inflammation of the lining of the
stomach and the bowel, stuffy nose

• Blood disorders characterised by fever or chills,
sore throat, ulcers in your mouth or throat

• Allergic reactions
• Nervousness, difficulty sleeping
• Dizziness, sleepiness, taste disorders, pins and
needles or numbness

Dosage
Azithromycin suspension should be administered
in one single daily dose, with or without food.
Shake the bottle well before you use the
suspension.
The usual dose is:
Use in children and adolescents with a body
weight above 45 kg, adults and older people
The total dose of azithromycin is 37.5 ml
(1500 mg) over 3 days (12.5 ml (500 mg) once
daily). As an alternative, the dose can be
distributed over 5 days (12.5 ml (500 mg) as
one single dose on the first day and then 6.25 ml
(250 mg) once daily).
The dose for inflammation of the urethra or
cervix caused by Chlamydia is 25 ml (1000 mg)
in one single dose.
For sinusitis, treatment is aimed at adults and
adolescents over 16 years of age.

A. Instructions for the syringe
Filling the syringe with medicine
1. Shake the bottle before use and remove the
child-proof cap.
2. While the bottle is sitting on a firm, flat surface,
hold it steady with one hand. With the other
hand insert the tip of the syringe into the
suspension.
3. Slowly pull back the plunger of the syringe
so that the top edge of the black ring is level
with the graduation line indicated on the
syringe.
4. If large bubbles can be seen in the syringe,
slowly push the plunger back into the
syringe. This will force the medicine back
into the bottle. Repeat step 3 again.
5. Remove syringe from bottle.

of the heart beat (palpitations)

Please take this leaflet, any remaining medicine
and the container with you to the hospital or
doctor so that they know which medicine was
consumed.
If you forget to use Azithromycin
If you forget to take a dose, take that dose as
soon as you remember, unless it is nearly time
to take the next one. Do not take a double dose
to make up for a forgotten dose.

indigestion, difficulty swallowing

• Feeling bloated, dry mouth
• Belching, ulcers in the mouth, increased
salivation, loose stools

• Hepatitis (inflammation of the liver)
• Rash, itching, hives (nettle rash)
• Skin inflammation, dry skin, increased sweating
• Inflammation of the joint, muscle pain, back
pain, neck pain

• Painful and difficult urination
• Inflammation of the vagina, irregular menstrual
bleeding, testicle disorders

• Chest pain, swelling, feeling unwell, lethargy,
tiredness

• Swelling of the face, fever, pain
• Changes in liver enzymes and laboratory blood
values.

Ref: 1701/300517/3/B

Rare (may affect up to 1 in 1000 people):
• Agitation
• A feeling of things being unreal
• Teeth discolouration
• Abnormal liver function, jaundice (yellowish
pigmentation of the skin)
• Reddening and blistering of the skin when
exposed to sunlight.
Not known (frequency cannot be estimated
from the available data):
• Blood disorders characterised by unusual
bleeding or unexplained bruising, low blood
count causing unusual tiredness or weakness
• Aggression, anxiety, confusion, seeing or
hearing things not really there
• Fainting, fits, loss of sensation, hyperactivity,
alteration or loss of the sense of smell, loss
of the sense of taste, myasthenia gravis (fatigue
and exhaustion of the muscle, see ‘Warnings
and precautions’ above)
• Hearing disturbances including deafness and/or
ringing in the ears
• Change in heart rate
• Low blood pressure (which may be associated
with weakness, light headedness and fainting)
• Discolouration of the tongue, inflammation of the
pancreas causing nausea, vomiting, abdominal
pain, back pain
• Liver failure (rarely life-threatening)
• Rash with spots and blisters
• Joint pain
• Kidney problems.
The following side effects have been reported
in prophylactic treatment against
Mycobacterium Avium Complex (MAC):
Very common (may affect more than 1 in 10
people)
• Diarrhea
• Abdominal pain
• Feeling sick (nausea)
• Loose wind (flatulence)
• Abdominal discomfort
• Loose stools.
Common (may affect up to1 in 10 people):
• Lack of appetite (anorexia)
• Feeling dizzy (dizziness)
• Headache
• Sensations of pins and needles or numbness
(paraesthesia)
• Changes in your sense of taste (dysgeusia)
• Visual impairment
• Deafness
• Skin rashes
• Itching (pruritus)
• Joint pain (arthralgia)
• Fatigue.
Uncommon (may affect up to 1 in 100 people):
• Reduced sense of touch (hypoesthesia)
• Hearing loss or ringing in your ears
• Abnormality of the rhythm or rate and awareness
of the heart beat (palpitations)
• Liver problems such as hepatitis
• Blisters/bleeding of the lips, eyes, nose, mouth
and genitals, which may be caused by
Stevens-Johnson syndrome
• Allergic skin reactions such as being sensitive to
sunlight, red, flaking and swollen skin
• Weakness (asthenia)
• General feeling of being unwell (malaise).
Reporting of side effects
If you get side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.

5. HOW TO STORE AZITHROMYCIN
• KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN
• Do not use Azithromycin after the expiry date
that is stated on the carton or bottle label. If
your doctor tells you to stop taking this
medicine, return any unused medicine to your
pharmacist or safe disposal. Only keep this
medicine, if your doctor tells you to.
• Unopened bottles: Do not store above 25°C.
• After reconstitution do not store above 25°C and
use within 10 days.
• If your medicine becomes discoloured or shows
any other signs of deterioration, consult your
pharmacist who will tell you what to do.
• Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help to
protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Azithromycin contains
Each 5ml of reconstituted oral suspension
contains 200 mg azithromycin as dihydrate.
The other ingredients are colloidal anhydrous
silica E551, sucrose, xanthan gum E415,
trisodium phosphate anhydrous,
hydroxypropyl cellulose, cherry flavouring trusil,
vanilla flavour, banana flavour.
What Azithromycin looks like and contents of
the pack
Azithromycin is a white to yellowish-white powder.
Azithromycin are available in bottles of 30ml.
A dosing syringe and dosing spoon are provided
with the bottles.
Manufacturer and Licence Holder
Manufactured by Merckle GmbH, Ludwig Merckle
Straße 3, 89143 Blaubeuren, Germany and is
procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1701 - Azithromycin
200mg/5ml Powder
for Oral Suspension

Leaflet revision date: 30/05/17

Blind or partially sighted?
Is this leaflet hard to see
or read? Phone
Lexon (UK) Limited,
Tel: 01527 505414 for
help.
Blue Box
Preparation of the suspension
Your pharmacist should prepare the
suspension. If you notice that this has not
been done, then you should go back to the
pharmacy to have the suspension prepared.

PATIENT INFORMATION LEAFLET

Ref: 1701/300517/4/F

Azithromycin 200mg/5ml Powder for Oral Suspension
Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor.
This includes any possible side effects not
listed in this leaflet. See section 4.
Your medicine is called Azithromycin 200mg/5ml
Powder for oral suspension and will be referred to
as Azithromycin throughout the rest of this leaflet.
What is in this leaflet:
1. What Azithromycin is and what it is used for
2. What you need to know before you use
Azithromycin
3. How to use Azithromycin
4. Possible side effects
5. How to store Azithromycin
6. Contents of the pack and other information
1. WHAT AZITHROMYCIN IS AND WHAT IT IS
USED FOR
Azithromycin is one of a group of antibiotics
called macrolides. It is used to treat bacterial
infections caused by microorganisms such as
bacteria. These infections include:
• Chest infections such as acute bronchitis and
pneumonia
• Infections in your sinuses, throat, tonsils or
ears
• Mild to moderate skin and soft tissue infections,
e.g. infection of the hair follicles (folliculitis),
bacterial infection of the skin and its deeper
layers (cellulitis), skin infection with shiny red
swelling (erysipelas)
• Infections caused by a bacterium called
Chlamydia trachomatis. They can cause
inflammations of the tube that carries urine from
your bladder (urethra) or where your womb joins
your vagina (cervix).
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE AZITHROMYCIN
Do NOT use Azithromycin:

• If you are allergic (hypersensitive) to
azithromycin or any other macrolide or ketolide
antibiotic, e.g. erythromycin or telithromycin or
any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
Talk to your doctor before taking azithromycin if
you:
• have ever had a serious allergic reaction
causing swelling of the face and throat, possibly
with breathing problems
• have severe kidney problems: your doctor
may alter the dose
• have liver problems: your doctor may need to
monitor your liver function or stop the treatment
• are aware of ever being diagnosed to have
prolonged QT interval (a heart condition):
azithromycin is not recommended
• are aware that you have a slow or irregular
heart beat, or reduced heart function:
azithromycin is not recommended
• know that you have low levels of potassium
or magnesium in your blood: azithromycin is not
recommended

• are taking medicines known as antiarrhythmics
(used to treat abnormal heart rhythms), cisapride
(used to treat stomach problems) or terfenadine
(an antihistamine that is used to treat allergies):
azithromycin is not recommended
• are taking medicines known as ergot alkaloids
(such as ergotamine), which are used to treat
migraine: azithromycin is not recommended (see
‘Other medicines and Azithromycin’ below)
• have been diagnosed with a neurological
disease, which is a disease of the brain or
nervous system
• have mental, emotional or behavioural problems
• have a condition known as myasthenia gravis,
with fatigue and exhaustion of the muscles:
azithromycin may worsen or cause symptoms of
myasthenia.
If you develop severe and persistent diarrhoea
during or after treatment, especially if you notice
blood or mucus, tell your doctor immediately.
If your symptoms persist after the end of your
treatment with Azithromycin, or if you notice any
new and persistent symptoms, contact your
doctor.
Azithromycin is not recommended for patients
under 6 months of age.
Other medicines and azithromycin
Tell your doctor if you are taking, have recently
taken or might take any of the following
medicines:
• Antacids e.g. aluminium hydroxide: take
Azithromycin at least 1 hour before or 2
hours after taking an antacid
• Ergot derivatives, e.g. ergotamine (used to
treat migraine): Azithromycin should not be
taken at the same time as ergotism may develop
(a potentially serious side effect with numbness
or tingling sensations in the limbs, muscle
cramps, headaches, convulsions, abdominal or
chest pain)
• Coumarin type oral anticoagulants, e.g. warfarin
(used to stop the blood clotting): the risk of
bleeding may be increased
• Digoxin (used to treat heart failure): the levels of
digoxin in your blood may increase
• Zidovudine, nelfinavir (used in the treatment
of HIV): the levels of zidovudine or azithromycin
might be increased
• Rifabutin (used in the treatment of HIV and
bacterial infections including tuberculosis):
decreases in your number of white blood cells
could occur
• Cyclosporin (an immunosuppressant used
following organ transplant): cyclosporin levels
may be elevated. Your doctor will need to
monitor your cyclosporin blood levels
• Cisapride (used to treat stomach problems):
heart problems may occur
• Astemizole, terfenadine (antihistamines used
to treat allergic reactions): their effect might
be increased
• Alfentanil (a painkiller): the effect of alfentanil
might be increased
• Fluconazole (for fungal infections): the levels
of azithromycin might be reduced.

No interactions have been observed between
azithromycin and cetirizine (an antihistamine);
didanosine, efavirenz, indinavir (for HIV infection);
atorvastatin (for cholesterol and heart problems);
carbamazepine (for epilepsy); cimetidine (an
antacid); methylprednisolone (to suppress the
immune system); midazolam, triazolam
(sedatives); sildenafil (for impotence), theophylline
(for asthma) and trimethoprim/sulphamethoxazole
(an antibiotic combination).
AZITHROMYCIN with food and drink:
Oral suspension can be taken with or without
food and drink.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this
medicine.
There is insufficient information regarding the
safety of azithromycin during pregnancy and
breast-feeding. Consequently, Azithromycin is
not recommended if you are pregnant or planning
to become pregnant or breast-feeding.
However, your doctor may prescribe it under
serious circumstances.

Use in children and adolescents with a body
weight under 45 kg
The azithromycin suspension should be measured
as carefully as possible with the accompanying
dosing syringe for children with a weight of 10 to
15 kg. For children who weigh more than 15 kg,
the azithromycin suspension should be
administered with the help of the dosing spoon
according to the following plan:
Weight

3-day course

5-day course

10-15 kg

0.25 ml/kg
(10 mg/kg)
once daily on
days 1 to 3

0.25 ml/kg (10
mg/kg) once on
day 1, followed
by 0.125 ml
(5 mg/kg) once
daily on days 2
to 5

16-25 kg

5 ml (200 mg)
once daily on
days 1 to 3

5 ml (200 mg)
once on day 1,
followed by
2.5 ml
(100 mg) once
daily on days
2 to 5

26-35 kg

7.5 ml (300 mg)
once daily on
days 1 to 3

7.5 ml (300 mg)
once on day 1,
followed by
3.75 ml (150
mg) once daily
on days 2 to 5

Driving and using machines
Azithromycin is not expected to affect your ability
to drive or use machines.
Azithromycin powder for oral suspension contains
3.75 g of sucrose per 5 ml.

35-45 kg

10 ml (400 mg)
once daily on
days 1 to 3

If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.
>45 kg

The sucrose content should be taken into account
in patients with diabetes mellitus.
3. HOW TO USE AZITHROMYCIN
Always use Azithromycin exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.
Preparation of the suspension
By the pharmacist: your pharmacist should
prepare the suspension. If you notice that this was
not done, then you should go back to the
pharmacy to have the suspension prepared.
By yourself: follow the instructions in the blue box
of this leaflet. See blue box information.

10 ml (400 mg)
once on day 1,
followed by
5 ml (200 mg)
once daily on
days 2 to 5

Dose as with
adults

For the treatment of tonsillitis/pharyngitis in
children aged 2 years or more: Azithromycin in
a single dose of 10 mg/kg or 20 mg/kg for three
days, in which the maximum daily dose of 500 mg
should not be exceeded.

Giving the medicine using the syringe
1. Make sure the child is supported in an upright
position.
2. Put the tip of the syringe carefully into the
child’s mouth. Point the tip of the syringe
towards the inside of the cheek.
3. Slowly push down the plunger of the syringe:
Do not squirt it out quickly. The medicine will
trickle into the child's mouth.
4. Allow the child time to swallow the medicine.
5. Replace the child-proof cap on the bottle.
Wash the syringe as instructed below.
6. Where daily doses of less than 5 ml have been
given for three days, some suspension will
remain in the bottle. This remaining suspension
should be discarded.

If you stop taking Azithromycin
Do not stop taking your medicine without talking
to your doctor first even if you feel better. It is very
important that you keep taking Azithromycin for as
long as your doctor has told you to, otherwise the
infection may come back.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Azithromycin can cause side
effects, although not everybody gets them.

Cleaning and storing the syringe
Pull the plunger out of the syringe and wash
both parts by holding under warm running water or
by immersing in sterilising solution used for baby’s
feeding bottles, etc.
Dry the two parts. Push the plunger back into the
syringe. Keep it in a clean safe place with the
medicine. After you have given the child the final
dose of medicine, wrap the syringe in a sheet of
newspaper and put it in the rubbish bin.

If the following happens, stop taking
Azithromycin and tell your doctor immediately
or go to the casualty department at your
nearest hospital:
• An allergic reaction (swelling of the lips, face
or neck leading to severe difficulty in breathing;
skin rash or hives)
• Blisters/bleeding of the lips, eyes, nose, mouth
and genitals, which may be caused by
Stevens-Johnson syndrome or toxic epidermal
necrosis, which are serious illnesses
• An irregular heart beat
• Prolonged diarrhoea with blood and mucus.

B. Instructions for the spoon
The spoon should not be used for children less
than 3 years of age (less than 15 kg).

These are very serious but rare side effects. You
may need urgent medical attention or
hospitalisation.

Giving the medicine using the plastic spoon
1. A plastic double-ended spoon is provided
with the medicine. Check which end of the
spoon and to which level gives the dose
required. If you are unsure, check with your
doctor or pharmacist. Multi-dosing spoon
delivers doses as follows:
2.5 ml (100mg)
Small end
brimful

The following other side effects have been
reported:
Very common (may affect more than 1 in 10
people):
• Diarrhoea.
Common (may affect up to 1 in 10 people):

• Changes in the numbers of some white blood
cells and blood bicarbonate

3.75 ml (150mg) Large end
5 ml (200mg)

Large end

to graduation

• Headache
• Vomiting, stomach pain, feeling sick.

brimful
Uncommon (may affect up to 1 in 100 people):

Sinusistis
For the treatment of sinusitis, limited data is
available for the treament of children under 16
years of age.
Patients with kidney or liver problems:
You should tell your doctor if you have kidney or
liver problems as your doctor may need to alter
the normal dose.

2. Shake the bottle well and then remove the
child-proof cap.
3. Gently pour the medicine into the spoon as
required to give the correct dose.
4. Allow the patient to swallow the medicine
slowly.
5. Wash the spoon under warm, running water.
Dry and store it with the medicine in a safe
place.

• Yeast infection e.g. of the mouth (thrush), vaginal

WARNING: GIVE THE MEDICINE SLOWLY TO
THE CHILD WHILE HE/SHE IS SUPPORTED IN
AN UPRIGHT POSITION. THIS WILL AVOID THE
RISK OF CHOKING.

• Sight disorders
• Ear disorders
• Vertigo (spinning sensation)
• Abnormality of the rhythm or rate and awareness

If you use more Azithromycin than you should
If you (or someone else) have taken too much
Azithromycin, contact your doctor or pharmacist
immediately. An overdose is likely to cause
reversible hearing loss, severe nausea (feeling
sick), vomiting and diarrhoea.

• Hot flush
• Difficulty breathing
• Nose bleed
• Inflammation of the stomach, constipation, wind,

infection, pneumonia, bacterial infection

• Sore throat, inflammation of the lining of the
stomach and the bowel, stuffy nose

• Blood disorders characterised by fever or chills,
sore throat, ulcers in your mouth or throat

• Allergic reactions
• Nervousness, difficulty sleeping
• Dizziness, sleepiness, taste disorders, pins and
needles or numbness

Dosage
Azithromycin suspension should be administered
in one single daily dose, with or without food.
Shake the bottle well before you use the
suspension.
The usual dose is:
Use in children and adolescents with a body
weight above 45 kg, adults and older people
The total dose of azithromycin is 37.5 ml
(1500 mg) over 3 days (12.5 ml (500 mg) once
daily). As an alternative, the dose can be
distributed over 5 days (12.5 ml (500 mg) as
one single dose on the first day and then 6.25 ml
(250 mg) once daily).
The dose for inflammation of the urethra or
cervix caused by Chlamydia is 25 ml (1000 mg)
in one single dose.
For sinusitis, treatment is aimed at adults and
adolescents over 16 years of age.

A. Instructions for the syringe
Filling the syringe with medicine
1. Shake the bottle before use and remove the
child-proof cap.
2. While the bottle is sitting on a firm, flat surface,
hold it steady with one hand. With the other
hand insert the tip of the syringe into the
suspension.
3. Slowly pull back the plunger of the syringe
so that the top edge of the black ring is level
with the graduation line indicated on the
syringe.
4. If large bubbles can be seen in the syringe,
slowly push the plunger back into the
syringe. This will force the medicine back
into the bottle. Repeat step 3 again.
5. Remove syringe from bottle.

of the heart beat (palpitations)

Please take this leaflet, any remaining medicine
and the container with you to the hospital or
doctor so that they know which medicine was
consumed.
If you forget to use Azithromycin
If you forget to take a dose, take that dose as
soon as you remember, unless it is nearly time
to take the next one. Do not take a double dose
to make up for a forgotten dose.

indigestion, difficulty swallowing

• Feeling bloated, dry mouth
• Belching, ulcers in the mouth, increased
salivation, loose stools

• Hepatitis (inflammation of the liver)
• Rash, itching, hives (nettle rash)
• Skin inflammation, dry skin, increased sweating
• Inflammation of the joint, muscle pain, back
pain, neck pain

• Painful and difficult urination
• Inflammation of the vagina, irregular menstrual
bleeding, testicle disorders

• Chest pain, swelling, feeling unwell, lethargy,
tiredness

• Swelling of the face, fever, pain
• Changes in liver enzymes and laboratory blood
values.

Ref: 1701/300517/4/B

Rare (may affect up to 1 in 1000 people):
• Agitation
• A feeling of things being unreal
• Teeth discolouration
• Abnormal liver function, jaundice (yellowish
pigmentation of the skin)
• Reddening and blistering of the skin when
exposed to sunlight.
Not known (frequency cannot be estimated
from the available data):
• Blood disorders characterised by unusual
bleeding or unexplained bruising, low blood
count causing unusual tiredness or weakness
• Aggression, anxiety, confusion, seeing or
hearing things not really there
• Fainting, fits, loss of sensation, hyperactivity,
alteration or loss of the sense of smell, loss
of the sense of taste, myasthenia gravis (fatigue
and exhaustion of the muscle, see ‘Warnings
and precautions’ above)
• Hearing disturbances including deafness and/or
ringing in the ears
• Change in heart rate
• Low blood pressure (which may be associated
with weakness, light headedness and fainting)
• Discolouration of the tongue, inflammation of the
pancreas causing nausea, vomiting, abdominal
pain, back pain
• Liver failure (rarely life-threatening)
• Rash with spots and blisters
• Joint pain
• Kidney problems.
The following side effects have been reported
in prophylactic treatment against
Mycobacterium Avium Complex (MAC):
Very common (may affect more than 1 in 10
people)
• Diarrhea
• Abdominal pain
• Feeling sick (nausea)
• Loose wind (flatulence)
• Abdominal discomfort
• Loose stools.
Common (may affect up to1 in 10 people):
• Lack of appetite (anorexia)
• Feeling dizzy (dizziness)
• Headache
• Sensations of pins and needles or numbness
(paraesthesia)
• Changes in your sense of taste (dysgeusia)
• Visual impairment
• Deafness
• Skin rashes
• Itching (pruritus)
• Joint pain (arthralgia)
• Fatigue.
Uncommon (may affect up to 1 in 100 people):
• Reduced sense of touch (hypoesthesia)
• Hearing loss or ringing in your ears
• Abnormality of the rhythm or rate and awareness
of the heart beat (palpitations)
• Liver problems such as hepatitis
• Blisters/bleeding of the lips, eyes, nose, mouth
and genitals, which may be caused by
Stevens-Johnson syndrome
• Allergic skin reactions such as being sensitive to
sunlight, red, flaking and swollen skin
• Weakness (asthenia)
• General feeling of being unwell (malaise).
Reporting of side effects
If you get side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.

5. HOW TO STORE AZITHROMYCIN

• KEEP OUT OF THE SIGHT AND REACH OF







CHILDREN
Do not use Azithromycin after the expiry date
that is stated on the carton or bottle label. If
your doctor tells you to stop taking this
medicine, return any unused medicine to your
pharmacist or safe disposal. Only keep this
medicine, if your doctor tells you to.
Unopened bottles: Do not store above 25°C.
After reconstitution do not store above 25°C and
use within 10 days
If your medicine becomes discoloured or shows
any other signs of deterioration, consult your
pharmacist who will tell you what to do.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help to
protect the environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Azithromycin contains
Each 5ml of reconstituted oral suspension
contains 200 mg azithromycin as dihydrate.
The other ingredients are colloidal anhydrous
silica E551, sucrose, xanthan gum E415,
trisodium phosphate anhydrous,
hydroxypropyl cellulose, cherry flavouring trusil,
vanilla flavour, banana flavour.
What Azithromycin looks like and contents of
the pack
Azithromycin is a white to yellowish-white powder.
Azithromycin are available in bottles of 30ml.
A dosing syringe and dosing spoon are provided
with the bottles.
Manufacturer and Licence Holder
Manufactured by TEVA Sante, Rue Bellocier,
89107 Sens, France and is procured from within
the EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1701 - Azithromycin
200mg/5ml Powder
for Oral Suspension

Leaflet revision date: 30/05/17

Blind or partially sighted?
Is this leaflet hard to see
or read? Phone
Lexon (UK) Limited,
Tel: 01527 505414 for
help.
Blue Box
Preparation of the suspension
Your pharmacist should prepare the
suspension. If you notice that this has not
been done, then you should go back to the
pharmacy to have the suspension prepared.

PATIENT INFORMATION LEAFLET

Ref: 1701/300517/5/F

Azithromycin 200mg/5ml Powder for Oral Suspension
Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor.
This includes any possible side effects not
listed in this leaflet. See section 4.
Your medicine is called Azithromycin 200mg/5ml
Powder for oral suspension and will be referred to
as Azithromycin throughout the rest of this leaflet.
What is in this leaflet:
1. What Azithromycin is and what it is used for
2. What you need to know before you use
Azithromycin
3. How to use Azithromycin
4. Possible side effects
5. How to store Azithromycin
6. Contents of the pack and other information
1. WHAT AZITHROMYCIN IS AND WHAT IT IS
USED FOR
Azithromycin is one of a group of antibiotics
called macrolides. It is used to treat bacterial
infections caused by microorganisms such as
bacteria. These infections include:
• Chest infections such as acute bronchitis and
pneumonia
• Infections in your sinuses, throat, tonsils or
ears
• Mild to moderate skin and soft tissue infections,
e.g. infection of the hair follicles (folliculitis),
bacterial infection of the skin and its deeper
layers (cellulitis), skin infection with shiny red
swelling (erysipelas)
• Infections caused by a bacterium called
Chlamydia trachomatis. They can cause
inflammations of the tube that carries urine from
your bladder (urethra) or where your womb joins
your vagina (cervix).
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE AZITHROMYCIN
Do NOT use Azithromycin:

• If you are allergic (hypersensitive) to
azithromycin or any other macrolide or ketolide
antibiotic, e.g. erythromycin or telithromycin or
any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
Talk to your doctor before taking azithromycin if
you:
• have ever had a serious allergic reaction
causing swelling of the face and throat, possibly
with breathing problems
• have severe kidney problems: your doctor
may alter the dose
• have liver problems: your doctor may need to
monitor your liver function or stop the treatment
• are aware of ever being diagnosed to have
prolonged QT interval (a heart condition):
azithromycin is not recommended
• are aware that you have a slow or irregular
heart beat, or reduced heart function:
azithromycin is not recommended
• know that you have low levels of potassium
or magnesium in your blood: azithromycin is not
recommended

• are taking medicines known as antiarrhythmics
(used to treat abnormal heart rhythms), cisapride
(used to treat stomach problems) or terfenadine
(an antihistamine that is used to treat allergies):
azithromycin is not recommended
• are taking medicines known as ergot alkaloids
(such as ergotamine), which are used to treat
migraine: azithromycin is not recommended (see
‘Other medicines and Azithromycin’ below)
• have been diagnosed with a neurological
disease, which is a disease of the brain or
nervous system
• have mental, emotional or behavioural problems
• have a condition known as myasthenia gravis,
with fatigue and exhaustion of the muscles:
azithromycin may worsen or cause symptoms of
myasthenia.
If you develop severe and persistent diarrhoea
during or after treatment, especially if you notice
blood or mucus, tell your doctor immediately.
If your symptoms persist after the end of your
treatment with Azithromycin, or if you notice any
new and persistent symptoms, contact your
doctor.
Azithromycin is not recommended for patients
under 6 months of age.
Other medicines and azithromycin
Tell your doctor if you are taking, have recently
taken or might take any of the following
medicines:
• Antacids e.g. aluminium hydroxide: take
Azithromycin at least 1 hour before or 2
hours after taking an antacid
• Ergot derivatives, e.g. ergotamine (used to
treat migraine): Azithromycin should not be
taken at the same time as ergotism may develop
(a potentially serious side effect with numbness
or tingling sensations in the limbs, muscle
cramps, headaches, convulsions, abdominal or
chest pain)
• Coumarin type oral anticoagulants, e.g. warfarin
(used to stop the blood clotting): the risk of
bleeding may be increased
• Digoxin (used to treat heart failure): the levels of
digoxin in your blood may increase
• Zidovudine, nelfinavir (used in the treatment
of HIV): the levels of zidovudine or azithromycin
might be increased
• Rifabutin (used in the treatment of HIV and
bacterial infections including tuberculosis):
decreases in your number of white blood cells
could occur
• Cyclosporin (an immunosuppressant used
following organ transplant): cyclosporin levels
may be elevated. Your doctor will need to
monitor your cyclosporin blood levels
• Cisapride (used to treat stomach problems):
heart problems may occur
• Astemizole, terfenadine (antihistamines used
to treat allergic reactions): their effect might
be increased
• Alfentanil (a painkiller): the effect of alfentanil
might be increased
• Fluconazole (for fungal infections): the levels
of azithromycin might be reduced.

No interactions have been observed between
azithromycin and cetirizine (an antihistamine);
didanosine, efavirenz, indinavir (for HIV infection);
atorvastatin (for cholesterol and heart problems);
carbamazepine (for epilepsy); cimetidine (an
antacid); methylprednisolone (to suppress the
immune system); midazolam, triazolam
(sedatives); sildenafil (for impotence), theophylline
(for asthma) and trimethoprim/sulphamethoxazole
(an antibiotic combination).
AZITHROMYCIN with food and drink:
Oral suspension can be taken with or without
food and drink.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this
medicine.
There is insufficient information regarding the
safety of azithromycin during pregnancy and
breast-feeding. Consequently, Azithromycin is
not recommended if you are pregnant or planning
to become pregnant or breast-feeding.
However, your doctor may prescribe it under
serious circumstances.

Use in children and adolescents with a body
weight under 45 kg
The azithromycin suspension should be measured
as carefully as possible with the accompanying
dosing syringe for children with a weight of 10 to
15 kg. For children who weigh more than 15 kg,
the azithromycin suspension should be
administered with the help of the dosing spoon
according to the following plan:
Weight

3-day course

5-day course

10-15 kg

0.25 ml/kg
(10 mg/kg)
once daily on
days 1 to 3

0.25 ml/kg (10
mg/kg) once on
day 1, followed
by 0.125 ml
(5 mg/kg) once
daily on days 2
to 5

16-25 kg

5 ml (200 mg)
once daily on
days 1 to 3

5 ml (200 mg)
once on day 1,
followed by
2.5 ml
(100 mg) once
daily on days
2 to 5

26-35 kg

7.5 ml (300 mg)
once daily on
days 1 to 3

7.5 ml (300 mg)
once on day 1,
followed by
3.75 ml (150
mg) once daily
on days 2 to 5

Driving and using machines
Azithromycin is not expected to affect your ability
to drive or use machines.
Azithromycin powder for oral suspension contains
3.75 g of sucrose per 5 ml.

35-45 kg

10 ml (400 mg)
once daily on
days 1 to 3

If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.
>45 kg

The sucrose content should be taken into account
in patients with diabetes mellitus.
3. HOW TO USE AZITHROMYCIN
Always use Azithromycin exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.
Preparation of the suspension
By the pharmacist: your pharmacist should
prepare the suspension. If you notice that this was
not done, then you should go back to the
pharmacy to have the suspension prepared.
By yourself: follow the instructions in the blue box
of this leaflet. See blue box information.
Dosage
Azithromycin suspension should be administered
in one single daily dose, with or without food.
Shake the bottle well before you use the
suspension.
The usual dose is:
Use in children and adolescents with a body
weight above 45 kg, adults and older people
The total dose of azithromycin is 37.5 ml
(1500 mg) over 3 days (12.5 ml (500 mg) once
daily). As an alternative, the dose can be
distributed over 5 days (12.5 ml (500 mg) as
one single dose on the first day and then 6.25 ml
(250 mg) once daily).
The dose for inflammation of the urethra or
cervix caused by Chlamydia is 25 ml (1000 mg)
in one single dose.
For sinusitis, treatment is aimed at adults and
adolescents over 16 years of age.

10 ml (400 mg)
once on day 1,
followed by
5 ml (200 mg)
once daily on
days 2 to 5

Dose as with
adults

For the treatment of tonsillitis/pharyngitis in
children aged 2 years or more: Azithromycin in
a single dose of 10 mg/kg or 20 mg/kg for three
days, in which the maximum daily dose of 500 mg
should not be exceeded.
Sinusistis
For the treatment of sinusitis, limited data is
available for the treament of children under 16
years of age.
Patients with kidney or liver problems:
You should tell your doctor if you have kidney or
liver problems as your doctor may need to alter
the normal dose.
A. Instructions for the syringe
Filling the syringe with medicine
1. Shake the bottle before use and remove the
child-proof cap.
2. While the bottle is sitting on a firm, flat surface,
hold it steady with one hand. With the other
hand insert the tip of the syringe into the
suspension.
3. Slowly pull back the plunger of the syringe
so that the top edge of the black ring is level
with the graduation line indicated on the
syringe.
4. If large bubbles can be seen in the syringe,
slowly push the plunger back into the
syringe. This will force the medicine back
into the bottle. Repeat step 3 again.
5. Remove syringe from bottle.

Giving the medicine using the syringe
1. Make sure the child is supported in an upright
position.
2. Put the tip of the syringe carefully into the
child’s mouth. Point the tip of the syringe
towards the inside of the cheek.
3. Slowly push down the plunger of the syringe:
Do not squirt it out quickly. The medicine will
trickle into the child's mouth.
4. Allow the child time to swallow the medicine.
5. Replace the child-proof cap on the bottle.
Wash the syringe as instructed below.
6. Where daily doses of less than 5 ml have been
given for three days, some suspension will
remain in the bottle. This remaining suspension
should be discarded.

If you stop taking Azithromycin
Do not stop taking your medicine without talking
to your doctor first even if you feel better. It is very
important that you keep taking Azithromycin for as
long as your doctor has told you to, otherwise the
infection may come back.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Azithromycin can cause side
effects, although not everybody gets them.

Cleaning and storing the syringe
Pull the plunger out of the syringe and wash
both parts by holding under warm running water or
by immersing in sterilising solution used for baby’s
feeding bottles, etc.
Dry the two parts. Push the plunger back into the
syringe. Keep it in a clean safe place with the
medicine. After you have given the child the final
dose of medicine, wrap the syringe in a sheet of
newspaper and put it in the rubbish bin.

If the following happens, stop taking
Azithromycin and tell your doctor immediately
or go to the casualty department at your
nearest hospital:
• An allergic reaction (swelling of the lips, face
or neck leading to severe difficulty in breathing;
skin rash or hives)
• Blisters/bleeding of the lips, eyes, nose, mouth
and genitals, which may be caused by
Stevens-Johnson syndrome or toxic epidermal
necrosis, which are serious illnesses
• An irregular heart beat
• Prolonged diarrhoea with blood and mucus.

B. Instructions for the spoon
The spoon should not be used for children less
than 3 years of age (less than 15 kg).

These are very serious but rare side effects. You
may need urgent medical attention or
hospitalisation.

Giving the medicine using the plastic spoon
1. A plastic double-ended spoon is provided
with the medicine. Check which end of the
spoon and to which level gives the dose
required. If you are unsure, check with your
doctor or pharmacist. Multi-dosing spoon
delivers doses as follows:
2.5 ml (100mg)
Small end
brimful

The following other side effects have been
reported:
Very common (may affect more than 1 in 10
people):
• Diarrhoea.

3.75 ml (150mg) Large end
5 ml (200mg)

Large end

to graduation
brimful

Common (may affect up to 1 in 10 people):

• Changes in the numbers of some white blood
cells and blood bicarbonate

• Headache
• Vomiting, stomach pain, feeling sick.
Uncommon (may affect up to 1 in 100 people):

2. Shake the bottle well and then remove the
child-proof cap.
3. Gently pour the medicine into the spoon as
required to give the correct dose.
4. Allow the patient to swallow the medicine
slowly.
5. Wash the spoon under warm, running water.
Dry and store it with the medicine in a safe
place.

• Yeast infection e.g. of the mouth (thrush), vaginal

WARNING: GIVE THE MEDICINE SLOWLY TO
THE CHILD WHILE HE/SHE IS SUPPORTED IN
AN UPRIGHT POSITION. THIS WILL AVOID THE
RISK OF CHOKING.

• Sight disorders
• Ear disorders
• Vertigo (spinning sensation)
• Abnormality of the rhythm or rate and awareness

If you use more Azithromycin than you should
If you (or someone else) have taken too much
Azithromycin, contact your doctor or pharmacist
immediately. An overdose is likely to cause
reversible hearing loss, severe nausea (feeling
sick), vomiting and diarrhoea.

• Hot flush
• Difficulty breathing
• Nose bleed
• Inflammation of the stomach, constipation, wind,

infection, pneumonia, bacterial infection

• Sore throat, inflammation of the lining of the
stomach and the bowel, stuffy nose

• Blood disorders characterised by fever or chills,
sore throat, ulcers in your mouth or throat

• Allergic reactions
• Nervousness, difficulty sleeping
• Dizziness, sleepiness, taste disorders, pins and
needles or numbness

of the heart beat (palpitations)

Please take this leaflet, any remaining medicine
and the container with you to the hospital or
doctor so that they know which medicine was
consumed.
If you forget to use Azithromycin
If you forget to take a dose, take that dose as
soon as you remember, unless it is nearly time
to take the next one. Do not take a double dose
to make up for a forgotten dose.

indigestion, difficulty swallowing

• Feeling bloated, dry mouth
• Belching, ulcers in the mouth, increased
salivation, loose stools

• Hepatitis (inflammation of the liver)
• Rash, itching, hives (nettle rash)
• Skin inflammation, dry skin, increased sweating
• Inflammation of the joint, muscle pain, back
pain, neck pain

• Painful and difficult urination
• Inflammation of the vagina, irregular menstrual
bleeding, testicle disorders

• Chest pain, swelling, feeling unwell, lethargy,
tiredness

• Swelling of the face, fever, pain
• Changes in liver enzymes and laboratory blood
values.

Ref: 1701/300517/5/B

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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